- Organization name
- UDI-DI code
- Reference / catalog number
FR-MF-000002870SOPHY® ADJUSTMENT KIT is an EU MDR-regulated medical device registered in EUDAMED. It is classified as Class I. Manufactured by SOPHYSA. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on Dec 22, 2025
376012413SAK000W4Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
(01)03760124131994
The compliance carrier: encodes the device identifier plus the production identifiers (lot, serial, dates) registered for this device.
4 warnings recorded — scroll inside the panel to see all entries.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
Contains latex
A "contains latex" flag warns that a device contains natural rubber latex, which can trigger allergic reactions in sensitive patients.
CMR substance
A CMR flag warns that a device contains a substance that is carcinogenic, mutagenic or toxic to reproduction above a defined threshold.
Endocrine-disrupting substance
An endocrine-disruptor flag warns that a device contains a substance with endocrine-disrupting properties above a defined threshold.
Primary placement in Germany; available across 1 country total.
Placed on the market in Germany; per-country availability dates not published.
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
03760124131994Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
376012413SAK000W4SAKUDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
MDR risk classes
MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.
European Medical Device Nomenclature — the EU product classification assigned to this device.
N0199ENCEPHALIC AND PERIPHERAL NERVOUS SYSTEM DEVICES - OTHERNo certificate specifically references this device's Basic UDI-DI.
Certificate health across this manufacturer's portfolio.
40615Issued40171SupplementedNotified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →Notified body
A notified body is an independent organisation, designated by an EU country, that audits manufacturers and certifies higher-risk devices before they can be CE-marked.
View in glossary →B-03760124130133On the marketRIGHT ANGLE VENTRICULAR CATHETER 9 CMB-03760124130140On the marketSiphonX® GRAVITATIONAL ANTI-SIPHON DEVICEB-03760124131697On the marketSOPHY® MINI ADJUSTABLE VALVE/ 8 PRESSB-03760124131093On the marketSOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 10-140B-03760124131109On the marketSOPHY® MINI ADJUSTABLE VALVE/ 8 PRESS. 50-300B-03760124131185On the market